Recent Developments in Australian & US Patent Law & their Impact ...

Momenta Pharmaceuticals v. Amphastar
Pharmaceuticals, Inc. (Fed. Cir. 2012)
Ausbiotech 2012 – Australian and US Patent Law
1 November 2012
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Federal Circuit construed the safe-harbor provision to protect Amphastar’s post-marketing activities
because, even though the information is not submitted to the FDA, but merely kept available as proof
of compliance in the event of FDA inspection, the testing results are needed to comply with
Amphastar’s ANDA to ensure that each new batch of the generic drug meets the equivalency
requirements.
The court found ample support in the Supreme Court’s decision of Merck v. Integra (2005). So long
as the information is of the kind that would be submitted to the FDA, the activities are “reasonably
related” and thus fall under the exemption, even though the research was aimed at developing new
drugs and not at developing generic versions of an already approved drug.
Denying safe-harbor protection just because the information is ultimately not submitted would stifle
innovation as one cannot predict which drug candidate will be successful and lead to information that
will be submitted to the FDA.”